The Food and Drug Administration (FDA) and Consumer Product Safety Commission (CPSC) have worked with manufacturers, health care practitioners, and consumer representatives to develop a voluntary consensus standard that applies to all adult portable adult bed rails, whether they are regulated by the FDA or the CPSC, to assure there are no gaps in federal oversight of the safety of these products. ASTM F3186-17: Standard Specification for Adult Portable Bed Rails and Related Products was published in 2017 and is recognized by the FDA. This standard establishes performance criteria for adult portable bed rails including resistance to entrapment. The FDA oversees adult portable bed rails for medical purposes and recommends that manufacturers of adult portable bed rails follow ASTM F3186-17. In addition, the FDA requires manufacturers, importers, and user facilities to report certain device-related adverse events and product problems to the FDA. See Medical Device Reporting (MDR): How to Report Medical Device Problems. The CPSC oversees adult portable bed rails not intended for medical purposes.

The FDA also oversees bed rails used on hospital beds as part of hospital bed systems and provides manufacturers of bed rails with guidance on the design of safe and effective hospital beds, including many resources on bed rail safety on Hospital Beds | FDA. Additional information is available in the Guidance for Industry and FDA Staff - Hospital Bed System Dimensional and Assessment Guidance to Reduce Entrapment.

For up-to-date information on recalls of Adult Portable Bed Rails visit:

• Medical Device Recalls | FDA
• CPSC Recalls